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This study is designed to evaluate the cosmetic benefit provided by twice daily application of a developmental moisturising cream with niacinamide for 8 weeks in healthy female participants with sensitive, oily, blemish-prone skin.
This study broadly consists of two phases: screening / washout phase (5-7 day) followed by treatment phase (approximately of 8 weeks). Participants will be asked to return to the study site 1 week, 4 weeks and 8 weeks after their randomisation visit for instrumental measurements and clinical assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No treatment and Standard cleanser | Placebo Comparator | Participants randomised to the no treatment regimen will use the standard cleanser (only) twice a day (morning and night). Morning and evening applications should be separated by at least 8 hours. |
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| Test product and Standard cleanser | Experimental | Participants randomised to test product regimen will be instructed to use the standard cleanser and test product twice a day (morning and night). Morning and evening applications should be separated by at least 8 hours. Participants will be instructed to apply the test product cream immediately after cleansing. |
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| Positive control and positive cleanser | Active Comparator | Participants randomised to positive control regimen will be instructed to use the positive cleanser and positive control product twice a day (morning and night). Morning and evening applications should be separated by at least 8 hours. Participants will be instructed to apply the positive control cream immediately after cleansing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Washout / Standard Cleanser | Other | Participants will apply standard cleanser (Simple Kind to Skin Moisturising Facial Wash) twice daily (morning and night) with at least 8 hours between product applications. Participants will use the standard cleanser in a 5-7 day washout period and during the test phase of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Corneometer Values at 8 Hours on Day 1 | A blinded, trained and qualified evaluator conducted instrumental measurements of skin moisturization.Measurement of skin moisturization was performed by the electrical capacitance method with a Corneometer CM 865. The measuring principle was based on changes in the capacitance of the measuring head, functioning as a condensator. Between the conductors of the probe an electrical field was built which allows the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content.The range of hydration level was 0 (as dry as possible)~120 AU (Arbitrary Unit)(most moist possible).Higher Corneometer values are indicative of improved skin moisturization. | At Baseline and Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Corneometer Values at 1 and 3 Hours on Day 1 and at Week 1, 4 and 8 | A blinded, trained and qualified evaluator conducted instrumental measurements of skin moisturisation. Measurement of skin moisturisation was performed by the electrical capacitance method with a Corneometer CM 865. The measuring principle was based on changes in the capacitance of the measuring head, functioning as a condensator. Between the conductors of the probe an electrical field was built which allows the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content. Higher Corneometer values are indicative of improved skin moisturisation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Valinhos | 13271-130 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31461548 | Result | Santos-Caetano JP, Gfeller CF, Mahalingam H, Thompson M, Moore DJ, Vila R, Doi R, Cargill MR. Cosmetic benefits of a novel biomimetic lamellar formulation containing niacinamide in healthy females with oily, blemish-prone skin in a randomized proof-of-concept study. Int J Cosmet Sci. 2020 Feb;42(1):29-35. doi: 10.1111/ics.12576. Epub 2020 Jan 6. |
| Label | URL |
|---|---|
| Cosmetic benefits of a novel biomimetic lamellar formulation containing niacinamide in healthy females with oily, blemish-prone skin in a randomised proof-of-concept study. | View source |
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Out of 205 screened participants,157 participants were enrolled, and 132 participants were randomized. 25 enrolled subjects were not subsequently randomized. Out of 132 randomized participants,1 participant was misallocated to treatment (received "no treatment" instead of "positive control").
All the participants were recruited from one center in Brazil.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Product Regimen | Participants randomized to test product regimen used the standard cleanser and test product twice a day (morning and night). Morning and evening applications were separated by at least 8 hours. Participants applied the test product cream immediately after cleansing. |
| FG001 | No Treatment Regimen | Participants randomized to the no treatment regimen used the standard cleanser (only) twice a day (morning and night). Morning and evening applications were separated by at least 8 hours. |
| FG002 | Positive Control Regimen | Participants randomized to positive control regimen used the positive cleanser and positive control product twice a day (morning and night). Morning and evening applications were separated by at least 8 hours. Participants applied the positive control cream immediately after cleansing. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Safety population(N=132) included all participants who were randomized and received at least 1 dose of study product.1 participant was misallocated to treatment (received "no treatment" instead of "positive control").Total of 45 and 43 participants were included in safety population for "no treatment" and "positive control" respectively.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Product Regimen | Participants randomized to test product regimen used the standard cleanser and test product twice a day (morning and night). Morning and evening applications were separated by at least 8 hours. Participants applied the test product cream immediately after cleansing. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Corneometer Values at 8 Hours on Day 1 | A blinded, trained and qualified evaluator conducted instrumental measurements of skin moisturization.Measurement of skin moisturization was performed by the electrical capacitance method with a Corneometer CM 865. The measuring principle was based on changes in the capacitance of the measuring head, functioning as a condensator. Between the conductors of the probe an electrical field was built which allows the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content.The range of hydration level was 0 (as dry as possible)~120 AU (Arbitrary Unit)(most moist possible).Higher Corneometer values are indicative of improved skin moisturization. | Intent to treat (ITT, N= 132) population included all participants who were randomized into the study and have at least one post-baseline measurement available. | Posted | Mean | Standard Deviation | Arbitrary Corneometer unit | At Baseline and Day 1 |
|
Approximately 57 days
1 participant was misallocated to treatment (received "no treatment" instead of "positive control"). This means 45 participants were in safety population for "no treatment".However, per convention, ITT population is defined based on intended treatment allocation.While 1 subject incorrectly received "no treatment",they were initially allocated to "positive control". Therefore, this participant was included in ITT population for "positive control" but safety population for "no treatment".
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Product Regimen | Participants randomized to test product regimen used the standard cleanser and test product twice a day (morning and night). Morning and evening applications were separated by at least 8 hours. Participants applied the test product cream immediately after cleansing. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HEADACHE | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 23, 2017 | Aug 31, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 20, 2017 | Jan 21, 2020 | SAP_001.pdf |
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|
| Test product | Other | Participants will apply 0.6 gram (g) of Test product (Moisturising Cream with Niacinamide) twice daily (morning and night) with at least 8 hours between product applications. Participants will use the test product during the test phase of the study. |
|
| Positive control cleanser | Other | Participants will apply positive control cleanser (Neutrogena Visibly Clear Spot Clearing Facial Wash) twice daily (morning and night) with at least 8 hours between product applications. Participants will use the positive control cleanser during the test phase of the study. |
|
| Positive control moisturiser | Other | Participants will apply 0.6 g of positive control moisturiser (Vivatinell Acnecinamide Gel Cream) twice daily (morning and night) with at least 8 hours between product applications. Participants will use the positive control moisturiser during the test phase of the study. |
|
| At Baseline, Day 1, Week 1, 4 and 8 |
| Odds for Logistic Regression Analysis on Improvement Rating of Lay Person Assessment of Polarized and Non-polarized Images Week 8 Compared to Baseline | The baseline and week 8 photographs of all participants were displayed side by side on high resolution, color-calibrated display screen in room with neutral wall colors and standardized lighting and all practical efforts were made to minimize glare. The relative positioning (left and right) of baseline and week 8 photographs were blinded to evaluator and randomized. A technician used randomization schedule to display pair of images to lay evaluator. Lay evaluators judged magnitude of improvement in overall appearance of blemishes using the below criteria: Left=blemishes on left are more obvious than those on the right and Right=blemishes on right are more obvious than those on the left. Layperson ranked both left and right image as follows:1=Better;2=Worse. Odds was calculated from logistic regression including treatment and age stratum effects and exchangeable correlation. Odds=p/(1-p) where p was the probability of event that Week 8 was better than baseline. | At Baseline and Week 8 |
| ANOVA Analysis on Improvement Rating of Lay Person Assessment of Polarized and Non-polarized Images Week 8 Compared to Baseline | Baseline and Week 8 photographs of all participants were displayed side by side on high resolution, color-calibrated display screen in room with neutral wall colors and standardized lighting with minimized glare. Relative positioning (left and right) of baseline and Week 8 photographs were blinded to evaluator and randomized. Lay evaluators ranked magnitude of improvement in overall appearance of blemishes using below criteria: Left=blemishes on left are more obvious than those on right; Right=blemishes on right are more obvious than those on left. Lay evaluator ranking for each image pair was converted into a numerical score based on whether Baseline or Week 8 image was ranked better:0=Baseline image was better than Week 8 image,1=Week 8 image was better than Baseline image. Minimum score 0 corresponded to all baseline images being better than Week 8 images. Maximum score 1 corresponded to all Week 8 images being better than baseline images. Higher scores indicated better results. | At Baseline and Week 8 |
| Change From Baseline in Evaluator's Assessment of Total Blemish Count at Week 1, 4, and 8 | A treatment blind, trained and qualified evaluator counted the total number of facial blemishes on the forehead, cheeks and chin of the participants. | At Baseline, Week 1, 4 and 8 |
| Change From Baseline in Sebumeter Values at Week 1, 4 and 8 | A treatment blinded, trained and qualified evaluator conducted instrumental measurements of skin sebum levels. Measurement of skin sebum levels was performed by with a Sebumeter SM 815. The measurement principle of the SM 815 is based on grease spot photometry. The translucent tape of the device is brought into contact with skin and becomes increasingly transparent in response to surface oil. The tape is inserted into the aperture of the device and its transparency measured by light transmission, with increased transmission signifying increased oiliness. The software outputs mass sebum levels as a function of area. Sebumeter measurements were taken in triplicate at the central forehead (above the eyebrows) with the participant lying horizontally, on their back. | At Baseline, Week 1, 4 and 8 |
| Change From Baseline in Sebum Excretion Rate at Week 1, 4 and 8 | The forehead of each participant was thoroughly cleansed by the investigator or designee using cotton pads saturated with 70% Isopropyl Alcohol and, after 5 minutes, the central area of the forehead above the eyebrows was measured in triplicate with a Sebumeter. The same area was measured in triplicate 90 minutes after cleansing. The sebum excretion rate was calculated by the difference in 90th minutes and 5th minute Sebumeter values. | At Baseline, Week 1, 4 and 8 |
| Related Info | View source |
| Adverse Event |
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| Other (Protocol violation) |
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| No Treatment Regimen |
Participants randomized to the no treatment regimen used the standard cleanser (only) twice a day (morning and night). Morning and evening applications were separated by at least 8 hours. |
| BG002 | Positive Control Regimen | Participants randomized to positive control regimen used the positive cleanser and positive control product twice a day (morning and night). Morning and evening applications were separated by at least 8 hours. Participants applied the positive control cream immediately after cleansing. |
| BG003 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Test Product Regimen |
Participants randomized to test product regimen used the standard cleanser and test product twice a day (morning and night). Morning and evening applications were separated by at least 8 hours. Participants applied the test product cream immediately after cleansing. |
| OG001 | No Treatment Regimen | Participants randomized to the no treatment regimen used the standard cleanser (only) twice a day (morning and night). Morning and evening applications were separated by at least 8 hours. |
| OG002 | Positive Control Regimen | Participants randomized to positive control regimen used the positive cleanser and positive control product twice a day (morning and night). Morning and evening applications were separated by at least 8 hours. Participants applied the positive control cream immediately after cleansing. |
|
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| Secondary | Change From Baseline in Corneometer Values at 1 and 3 Hours on Day 1 and at Week 1, 4 and 8 | A blinded, trained and qualified evaluator conducted instrumental measurements of skin moisturisation. Measurement of skin moisturisation was performed by the electrical capacitance method with a Corneometer CM 865. The measuring principle was based on changes in the capacitance of the measuring head, functioning as a condensator. Between the conductors of the probe an electrical field was built which allows the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content. Higher Corneometer values are indicative of improved skin moisturisation. | ITT (N= 132) population included all participants who were randomized into the study and have at least one post-baseline measurement available. | Posted | Mean | Standard Deviation | Arbitrary Corneometer unit | At Baseline, Day 1, Week 1, 4 and 8 |
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| Secondary | Odds for Logistic Regression Analysis on Improvement Rating of Lay Person Assessment of Polarized and Non-polarized Images Week 8 Compared to Baseline | The baseline and week 8 photographs of all participants were displayed side by side on high resolution, color-calibrated display screen in room with neutral wall colors and standardized lighting and all practical efforts were made to minimize glare. The relative positioning (left and right) of baseline and week 8 photographs were blinded to evaluator and randomized. A technician used randomization schedule to display pair of images to lay evaluator. Lay evaluators judged magnitude of improvement in overall appearance of blemishes using the below criteria: Left=blemishes on left are more obvious than those on the right and Right=blemishes on right are more obvious than those on the left. Layperson ranked both left and right image as follows:1=Better;2=Worse. Odds was calculated from logistic regression including treatment and age stratum effects and exchangeable correlation. Odds=p/(1-p) where p was the probability of event that Week 8 was better than baseline. | ITT (N= 132) population included all participants who were randomized into the study and have at least one post-baseline measurement available. | Posted | Number | Odds | At Baseline and Week 8 |
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| Secondary | ANOVA Analysis on Improvement Rating of Lay Person Assessment of Polarized and Non-polarized Images Week 8 Compared to Baseline | Baseline and Week 8 photographs of all participants were displayed side by side on high resolution, color-calibrated display screen in room with neutral wall colors and standardized lighting with minimized glare. Relative positioning (left and right) of baseline and Week 8 photographs were blinded to evaluator and randomized. Lay evaluators ranked magnitude of improvement in overall appearance of blemishes using below criteria: Left=blemishes on left are more obvious than those on right; Right=blemishes on right are more obvious than those on left. Lay evaluator ranking for each image pair was converted into a numerical score based on whether Baseline or Week 8 image was ranked better:0=Baseline image was better than Week 8 image,1=Week 8 image was better than Baseline image. Minimum score 0 corresponded to all baseline images being better than Week 8 images. Maximum score 1 corresponded to all Week 8 images being better than baseline images. Higher scores indicated better results. | ITT (N= 132) population included all participants who were randomized into the study and have at least one post-baseline measurement available. | Posted | Least Squares Mean | Standard Error | Score on scale | At Baseline and Week 8 |
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| Secondary | Change From Baseline in Evaluator's Assessment of Total Blemish Count at Week 1, 4, and 8 | A treatment blind, trained and qualified evaluator counted the total number of facial blemishes on the forehead, cheeks and chin of the participants. | ITT (N= 132) population included all participants who were randomized into the study and have at least one post-baseline measurement available. | Posted | Mean | Standard Deviation | Total Blemish Count | At Baseline, Week 1, 4 and 8 |
|
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| Secondary | Change From Baseline in Sebumeter Values at Week 1, 4 and 8 | A treatment blinded, trained and qualified evaluator conducted instrumental measurements of skin sebum levels. Measurement of skin sebum levels was performed by with a Sebumeter SM 815. The measurement principle of the SM 815 is based on grease spot photometry. The translucent tape of the device is brought into contact with skin and becomes increasingly transparent in response to surface oil. The tape is inserted into the aperture of the device and its transparency measured by light transmission, with increased transmission signifying increased oiliness. The software outputs mass sebum levels as a function of area. Sebumeter measurements were taken in triplicate at the central forehead (above the eyebrows) with the participant lying horizontally, on their back. | ITT (N= 132) population included all participants who were randomized into the study and have at least one post-baseline measurement available. | Posted | Mean | Standard Deviation | Micrograms (μg)/square centimeter (cm^2) | At Baseline, Week 1, 4 and 8 |
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| Secondary | Change From Baseline in Sebum Excretion Rate at Week 1, 4 and 8 | The forehead of each participant was thoroughly cleansed by the investigator or designee using cotton pads saturated with 70% Isopropyl Alcohol and, after 5 minutes, the central area of the forehead above the eyebrows was measured in triplicate with a Sebumeter. The same area was measured in triplicate 90 minutes after cleansing. The sebum excretion rate was calculated by the difference in 90th minutes and 5th minute Sebumeter values. | ITT (N= 132) population included all participants who were randomized into the study and have at least one post-baseline measurement available. | Posted | Mean | Standard Deviation | μg/cm^2 | At Baseline, Week 1, 4 and 8 |
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| 0 |
| 44 |
| 0 |
| 44 |
| 1 |
| 44 |
| EG001 | No Treatment Regimen | Participants randomized to the no treatment regimen used the standard cleanser (only) twice a day (morning and night). Morning and evening applications were separated by at least 8 hours. | 0 | 45 | 0 | 45 | 2 | 45 |
| EG002 | Positive Control Regimen | Participants randomized to positive control regimen used the positive cleanser and positive control product twice a day (morning and night). Morning and evening applications were separated by at least 8 hours. Participants applied the positive control cream immediately after cleansing. | 0 | 43 | 0 | 43 | 5 | 43 |
| HYPERAESTHESIA | Nervous system disorders | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | Systematic Assessment |
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| NASAL DISCOMFORT | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| At 3 hour, Day 1 |
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| At Week 1 |
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| At Week 4 |
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| At Week 8 |
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| 0.8931 |
| Odds Ratio (OR) |
| 1.04 |
| 2-Sided |
| 95 |
| 0.61 |
| 1.78 |
| Superiority |
| Analysis of Lay Person Assessment Non-Polarised Image. | Odds Ratio | 0.0181 | Odds Ratio (OR) | 1.90 | 2-Sided | 95 | 1.12 | 3.25 | Superiority |
| Analysis of Lay Person Assessment Non-Polarised Image. | Odds Ratio | 0.8319 | Odds Ratio (OR) | 0.94 | 2-Sided | 95 | 0.55 | 1.63 | Superiority |
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Analysis of Lay Person Assessment Polarised Image.
| ANOVA |
ANOVA= average rate over all raters including effects of treatment and age stratum. |
| 0.8887 |
| Mean Difference (Final Values) |
| 0.01 |
| 2-Sided |
| 95 |
| -0.12 |
| 0.14 |
| Superiority |
| Analysis of Lay Person Assessment Non-Polarised Image. | ANOVA | ANOVA= average rate over all raters including effects of treatment and age stratum. | 0.0224 | Mean Difference (Final Values) | 0.15 | 2-Sided | 95 | 0.02 | 0.28 | Superiority |
| Analysis of Lay Person Assessment Non-Polarised Image. | ANOVA | ANOVA= average rate over all raters including effects of treatment and age stratum. | 0.8253 | Mean Difference (Final Values) | -0.01 | 2-Sided | 95 | -0.15 | 0.12 | Superiority |
| At Week 4 |
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| At Week 8 |
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| At Week 4 |
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| At Week 8 |
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| At Week 4 |
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| At Week 8 |
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